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510(k) Data Aggregation
(72 days)
ARMM, INC.
The irrigation tubing sets will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The sets will be attached to standard irrigation systems such as either gravity bag systems attached to I.V. standard neiganian a pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irrigant. The handle or accessory for irrigation would be attached to the end opposite the irrigant source.
The aspiration tubing sets will be used for the removal of fluids, air or debris left I fie aspiration the surgery. These sets could be used just to remove the flushing irrigant that is used to keep the surgical arena visible. One ond would be attached to the suction source and the other end would be attached to the suction tip handle.
The irrigation sets will be offered in different sizes with spikes and luer locks for attachments to the gravity bag feed systems. There would be four different size attaching to the grate to allow the customer to chose the most economical set according to what their requirements are. There would be one dual set with a wye and two pinch clamps to allow for the use of two supply bags. There would w one set offered with valves for the use of the bottle type supply systems so that clamps would not have to be activated for operation.
The aspiration tubing sets will be offered in different sizes with suction I no aspreaten and luer locks for those smaller sizes that require them for hooking them to the suction system. The larger sizes may be used by just pushing the tubing over the barbed connectors on the suction supply systems.
This document is a 510(k) Pre-Market Notification for the SuperFlow Irrigation and Aspiration Tubing Sets. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study would for a diagnostic or therapeutic device.
The document discusses the device's substantial equivalence to a predicate device (EndoSI Suction/Irrigator), focusing on design, composition, function, and biocompatibility. The "study" mentioned is primarily related to the validation of the sterilization process and biocompatibility testing, not a performance study against acceptance criteria from a clinical or diagnostic perspective.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this particular document.
Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence | "The safety and effectiveness of this device is substantially equivalent to that of the predicate device (The EndoSI Suction Irrigators) because the components are identical to those that have been used in the EndoSI Suction Irrigations." |
| Biocompatibility | "The tubing sets have been tested to be biocompatible." (Referenced Addendum IX for information) |
| Sterility Assurance Level (SAL) | "The sterility assurance level will be 10(-6)." |
| Sterilization Method Validation | "The sterilization process for the EndoSI Suction/Irrigator has been validated utilizing the guidelines issued by AAMI for Method I Radiation Sterilization. This validation will apply to the irrigation and aspiration tubing sets." |
| Radiation Dose | "Both of the irrigation and aspiration tubing sets will be processed on a production basis at 25 to 35 kGs." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document is a pre-market notification (510(k)) asserting substantial equivalence, not a report on a clinical or performance study that would have a test set for diagnostic accuracy or efficacy. The "testing" mentioned refers to biocompatibility and sterilization validation, not clinical performance. Specific sample sizes for these tests are not provided in the summary.
- Data Provenance: Not specified for any underlying biocompatibility or sterilization validation data within this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or adjudication process described in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical accessory (tubing sets) for irrigation and aspiration, not an AI-powered diagnostic or therapeutic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. The "ground truth" equivalent for this device is compliance with material safety (biocompatibility), manufacturing standards (sterilization validation), and demonstrating physical equivalence and functionality to the predicate device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device.
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